SINOMED(SH:688108) Xin Lang Cai Jing·2026-02-04 19:28Core Viewpoint - Sino Medical has received the Medical Device Registration Certificate for its drug-eluting stent system, marking a significant milestone in its product development and commercialization efforts [2][4]. Group 1: Medical Device Registration Details - The product is a drug-eluting stent system composed of a drug-coated stent and a rapid exchange balloon catheter delivery system [2]. - The stent is made from L605 cobalt-chromium alloy and features a non-degradable bottom coating and a biodegradable drug coating containing rapamycin and PLGA [2][3]. - The drug dosage density is 1.20 μg/mm², with a drug loading range of 59 μg to 324 μg [2]. Group 2: Product Specifications and Usage - The stent is designed for use in blood vessels with diameters ranging from 2.25 mm to 5.00 mm and is intended to alleviate symptoms of ischemic heart disease [2][3]. - The product has a shelf life of 18 months and is sterilized using electron beam technology for single-use [2]. Group 3: Impact on the Company - The approval of the drug-eluting stent system enhances the company's product portfolio and is expected to meet diverse market demands, potentially boosting sales and core competitiveness [4]. - The product is classified as a Class III medical device, requiring further production licensing before it can be manufactured and sold [4].